ClinicalTrials.gg
RecruitingNCT07901816Updated Nov 10, 2026

Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets for Pediatric Cancer Survivors and Their Families

An interventional study of Dietary Intervention - meal recipes and Informational Intervention in Pediatric, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care

Updated Nov 10, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

This clinical trial tests the feasibility, acceptability and effect of an optimal defaults grocery shopping intervention to promote healthy diets for pediatric cancer survivors and their families. Pediatric cancer survivors are a growing population who are at an increased risk of developing chronic conditions and treatment-related complications. Poor nutritional intake can significantly worsen chronic health conditions experienced by survivors. Children who have poorer nutrition post-treatment are at greater risk for cancer recurrence. Interventions that effectively support families in obtaining and consuming healthier food and improve dietary intake are poised to improve developmental outcomes among pediatric cancer survivors. One promising way to impact the family diet is by targeting food purchasing. Optimal defaults, or making the healthy choice the automatic choice, is a specific nudge strategy that may be a feasible, acceptable and effective way to promote healthier food purchasing and dietary intake among pediatric cancer survivors and their families.

Read the detailed description

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of an optimal defaults grocery shopping intervention among families with a survivor of pediatric cancer.

II. To test effects of the defaults intervention on the nutritional quality, energy content, and cost of household grocery purchases and children's usual dietary intake, including nutritional quality and energy intake, as well as intake of fat, carbohydrates, protein, and added sugar.

IIa. Examine effects of the intervention on dietary intake of the enrolled parent/guardian

OUTLINE:

Families (cancer survivor and their parent/legal guardian) shop for groceries as normal for 2 weeks, using Instacart for at least 75% of shopping, and provide receipts for this shopping. At the end of Week 2, families meet with study staff to address any grocery shopping questions. Families are then randomized to 1 of 2 groups.

GROUP 1: Families receive 4 recipes per week for 2 weeks while continuing to record their grocery shopping. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipes options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping questions.

GROUP 2: Families receive 4 recipes per week for 2 weeks, continue to record their grocery shopping, and have their online Instacart grocery carts prefilled with the ingredients needed to make the recipes. Families may make changes to their carts as they like. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipes options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping questions.

02

Conditions studied

  • Pediatric
03

In context

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Parent (or legal guardian) of child that is a survivor of pediatric cancer (any diagnosis)
  • Pediatric patient age: 2 ≤ age \< 17 years old at time of study entry
  • Child receiving follow-up care at the Roswell Park Comprehensive Cancer Center. The child should no longer be receiving active cancer directed therapy at time of enrollment. There is no limit to the time post treatment
  • Parent is the primary caregiver of the child. This is defined as being the parent/guardian who is the most aware of the child's daily activities (or one of multiple guardians who are equally aware)
  • Parent does at least 50% of the grocery shopping for the family
  • Can be current online grocery shopper or willing to online grocery shop during the study, meeting these requirements: ≥ 75% of their grocery shopping from 1 of 4 specific grocery stores via Instacart (Wegmans, Aldi, Tops, and/or Walmart)
  • Child eats ≥ 3 main meals at home with the participating parent per week
  • Family does not have any dietary restrictions that would preclude them from being able to use at least some recipes in the study's recipe bank. Most dietary restrictions and preferences (e.g., vegetarian, vegan, halal, gluten-free, allergies to or preferences to avoid particular specific foods) can be accommodated by our large and diverse recipe bank. Only more severe and extensive restrictions would render a family ineligible, such as not being able to eat foods across multiple major food groups
  • No history of eating disorders. This includes no history of eating disorders in the participating child's medical record. Parent will also be asked during the screening process to self-report whether or not they have ever been diagnosed with an eating disorder themself
  • Participant is not currently receiving supplemental nutritional support such as nasogastric tube (NG), gastrostomy tube (GT) or parenteral support
  • Participant is not actively utilizing a medically-tailored meal program, such as RxDiet
  • Parent age: > 18 years-old - NA (No Limit)
  • Parent fluent in English
  • Participant (or legal representative) must understand the nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written form prior to receiving any study related procedure

Exclusion criteria

Exclusion Criteria:

  • Parent is unwilling or unable to follow protocol requirements
  • Not meeting above inclusion criteria
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Group 1 - Main Meal Recipes

    Families (cancer survivor and their parent/legal guardian) shop for groceries as normal for 2 weeks, using Instacart for at least 75% of shopping, and provide receipts for this shopping. At the end of Week 2, families meet with study staff to address any grocery shopping questions. Families receive 4 recipes per week for 2 weeks while continuing to record their grocery shopping. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipe options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping questions.

    Other: Dietary Intervention - meal recipes · Other: Informational Intervention · Other: Educational Intervention

  • Experimental
    Group 2 - Main meal recipes, prefilled grocery cart

    Families (cancer survivor and their parent/legal guardian) shop for groceries as normal for 2 weeks, using Instacart for at least 75% of shopping, and provide receipts for this shopping. At the end of Week 2, families meet with study staff to address any grocery shopping questions. Families receive 4 recipes per week for 2 weeks, continue to record their grocery shopping, and have their online Instacart grocery carts prefilled with the ingredients needed to make the recipes. Families may make changes to their carts as they like. Recipe packets include 3 main meal recipes as well as an idea of an additional breakfast/lunch/snack that can be made with leftovers from the main meal recipes, nutritional characteristics of the recipes and some simple nutrition education tips. Recipe options can be assigned depending on families' dietary restrictions and food preferences. At the end of Week 4, families meet with study staff to address any grocery shopping concerns

    Other: Dietary Intervention - meal recipes · Other: Educational Intervention · Other: Dietary Intervention - prefilled grocery cart

Interventions

  • OtherDietary Intervention - meal recipes

    Receive main meal recipes

  • OtherInformational Intervention

    Meet with study staff to address any grocery shopping questions

  • OtherEducational Intervention

    Receive nutrition education tips

  • OtherDietary Intervention - prefilled grocery cart

    Receive prefilled online grocery cart

06

What researchers measure

Primary outcomes

  1. Retention Rate

    Percentage of study cohort who complete the study

    Time frame: At 4 weeks

  2. Percentage of Interested families Eligible for study

    Feasibility defined as ≥ 50% of interested families being eligible for the study

    Time frame: At 4 weeks

  3. Percentage of eligible families enrolling in study

    Feasibility defined as ≥ 50% of eligible families enrolling

    Time frame: At week 4

  4. Percent of enrolled families completing baseline measures and proceeding to randomization

    Feasibility defined as ≥ 90% of enrolled families successfully completing baseline measures and proceeding to randomization

    Time frame: At 4 weeks

  5. Percentage of randomized families completing the study

    Feasibility defined as ≥ 85% of randomized families completing the study.

    Time frame: At 4 weeks

  6. Participant reported interest in continuing to engage in program over a longer period of time.

    As reported by participants by Phone call

    Time frame: At 4 weeks

Secondary outcomes

  1. Change in household grocery purchases: nutritional quality

    Nutritional quality will be calculated based on quintiles for each of 13 indicators that correspond to the Healthy Eating Index: total fruit, whole fruit, total vegetables, dark green and legume vegetables, whole grains, dairy, total protein foods, seafood and plant proteins, the ratio of mono and polyunsaturated fatty acids to saturated fatty acids, refined grains, sodium, added sugars, and saturated fats. Quintile scores will be summed to generate nutritional quality of grocery purchases each week

    Time frame: From baseline to end of study - up to 4 weeks

  2. Changes in household grocery purchases: energy content

    Total energy content of groceries purchased for the household each week

    Time frame: UP to 4 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartEst.
Nov 2, 2026
Primary completionEst.
Nov 2, 2028
CompletionEst.
Nov 2, 2029
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 10, 2026
Sites
Roswell Park Comprehensive Cancer Center is now Recruiting
Nov 10, 2026
Registered
First appeared on the registry
Oct 28, 2026
Show all 2 updates
  1. Nov 10, 2026
    Not yet recruiting→Recruiting
    Roswell Park Comprehensive Cancer Center is now Recruiting
    + 1 other change: verification date
  2. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07901816
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Nov 2, 2028 (estimated)
Completion
Nov 2, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

ASK ROSWELLPARK
Contact
ASKROSWELL@Roswellpark.org
800-767-9355
Kara Kelly, MD
principal investigator · Roswell Park Comprehensive Cancer Center
Stephanie Anzman-Frasca, PhD
principal investigator · University at Buffalo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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